NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The accepted PIP calls for a completion date of summer 2028.

The EMA rules (that MHRA is likely still following) allow for deferrals of both completion and initiation. I would be virtually certain NWBO has no need to complete the PIP studies prior to MAA approval.

As far as initiation, I would think that depends on the details within the plan.

I did see someplace (forget where and would need to dig it up) that the RA (forget if EMA or MHRA) checks up at 2 years to insure the plan is on track. If so, that could be why LP mentions the trials have to start this year (the pan was approved Aug 2022).

In general though, I think the PIP program is more of a gentle pressure than a hard whip. It would be insane to keep useful drugs off the market for years.